Associate Director - Quality Digital Data - Europe - Homebased

Requisition Number: 7635

Position Title: Associate Director, Quality Digital Data

External Description:

Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Associate Director Quality Digital Data does at Worldwide

Responsible for quality operational oversight of GxP Quality activities with a focus on Computer System Validation (CSV), Electronic Records and Data and associated IT Quality activities including compliance for security/cyber security. Including managing Quality Issues, hosting audits and inspections at Worldwide, conducting/oversight of CSV audits of Worldwide eSystem vendors and QA oversight of contracts and quality agreements. Ensuring that GxP eSystem activities are consistent and meet both external and internal requirements. Provide assurance with SOPs, Regulations, and guidelines for Worldwide processes. 

 What you will do

• Champion and adhere to Worldwide's Quality Management System (QMS)
• Ensures Worldwide IT and computer systems supporting Worldwide pharmaceuticals research activities are conducted in compliance with GxP, EU Directives, International Conference on Harmonization (ICH) and Worldwide Policies and Procedures, as applicable
• Responsible for the GxP compliance of key eSystem vendors activities
• Manage QA liaison between designated vendors, Worldwide and Sponsors
• Vendor performance monitoring and ensure compliance to the Quality Agreement
• Perform CSV and IT related audits to ensure compliance with GMP, GDP, GVP and GCP and ensure the audits are reported and CAPA plans implemented to provide assurance of compliance with processes, regulations, guidelines, and agreements. Audits may be part of the internal audit or external vendor programs.
• Provides QA consultancy to the Worldwide operations relating to compliance requirements for electronic systems and data.

What you will bring to the role

• Demonstrate organizational and critical decision-making skills
• Facilitate group or project initiatives and build team unity
• Work with a sense of urgency and recognize time sensitivity
• Strong understanding of validation and IT requirements for GxP principles and processes
• Proficiency in Microsoft applications (Excel, Word, eQMS, PowerPoint)

Your experience

• Bachelor's degree or equivalent in a relevant field (e.g. Computer Science or other related science) and minimum 6 years of IT and CSV experience in a GCP, GLP, or GMP regulated environment
• at least 7 years of experience in quality and regulatory compliance roles for GxP activities (including QA audits particularly CSV/Digital data audits)
• Previous experience participating in regulatory inspections (FDA, MHRA, Health Canada, EMA)
• Excellent understanding of validation and IT requirements for GxP regulations and guidelines
• Knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree
• Understanding of risk-based approaches to auditing
• Familiarity with the Drug Development Process
• Domestic and limited international travel required (approximately 35-40%)

 

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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Employment Type: Regular

Community / Marketing Title: Associate Director - Quality Digital Data - Europe - Homebased

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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